AbbVie’s pan-genotypic hep C therapy cleared in the US

The therapy is a once-daily regimen combining two distinct antiviral agents - the NS3/4A protease inhibitor glecaprevir (300mg) and NS5A inhibitor pibrentasvir (120mg) - dosed once-daily as three oral tablets.

The US Food and Drug Administration has cleared Mavyret to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis.

It is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.

Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated, offering a shorter course that the previous 12 weeks of more with standard therapy.

The safety and efficacy of the regimen were evaluated in clinical trials enrolling around 2,300 adults with all HCV genotypes without cirrhosis or with mild cirrhosis. Data showed that 92-100 percent of patients who received Mavyret for eight, 12 or 16 weeks duration had no virus detected in the blood 12 weeks after finishing treatment, suggesting that patients’ infection had been cured.

The most common side effects reported were headache, fatigue and nausea.

"The clinical trial programme for Mavyret resulted in high cure rates across a range of patient populations, from those who have never been treated and who do not have cirrhosis, all the way to patients with compensated cirrhosis," said Fred Poordad, vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio. "This approval helps achieve physicians' goals of delivering effective options for a broad range of patients."